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Brain Imaging and Retreatment Study of Persistent Lyme Disease
This study is currently recruiting patients.
Sponsored by: | National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
Purpose
The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.
Condition | Treatment or Intervention | Phase |
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Lyme Disease Lyme Neuroborreliosis |
Drug: ceftriaxone |
Phase II |
MedlinePlus related topics: Bacterial Infections; Lyme Disease; Neurologic Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control
Official Title: PET and MRI Imaging of Persistent Lyme Encephalopathy
Expected Total Enrollment: 65
Study start: December 1999
Some people with a history of Lyme disease continue to have problems despite having received “textbook duration” antibiotic therapy. When memory, attention, or thinking problems persist, the syndrome is called persistent Lyme disease (PLD). This study seeks to answer critical scientific questions about the treatment and cause of PLD symptoms.
This 24-week treatment study will evaluate each patient’s response to treatment using neuropsychological testing and state-of-the-art brain imaging. The brain tests include neuropsychological testing of memory and attention, brain imaging (MRI and PET scans) to look at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and studies of the fluid that surrounds the brain (cerebrospinal fluid). The treatment involves 10 weeks of either intravenous antibiotic called ceftriaxone (also known as Rocephin) or intravenous placebo (inactive substance). After the first visit to Columbia Presbyterian Medical Center, the remaining treatments will be done in the patient’s home. Patients will be screened over the phone and in person to confirm study eligibility.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
Eligible participants must:
Exclusion Criteria:
Ineligible from participation are people with the following:
Twenty healthy subjects are also being sought for the study.
Location and Contact Information
More Information
Columbia's Lyme disease research studies website
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |